SUPPLEMENTS AND NATURAL HEALTH PRODUCTS

Globally, the dietary supplements and natural health products industry is currently believed to exceed $400 billion, with the subset of dietary supplements accounting for more than $37 billion in sales.

The dietary supplement/natural health product market is a broad category including everything from herbal products, vitamins, and minerals to omega-3s and probiotics. These products are regulated as dietary supplements in the US, natural health products (NHPs) in Canada, and food supplements in the EU.

How a product is classified can affect its entire life cycle, from early development to clinical research strategy, health claims substantiation, and positioning. The product type and its ingredients may span multiple regulatory categories, presenting different options for categorization and market entry. Ultimately, the label claims and safety profile dictate the appropriate classification.

Understanding the nuanced requirements of different categories can present new opportunities for market access. Our regulatory team will work with you to weigh the risks and benefits of different classification options and determine the optimal pathway depending on your objectives.

Subproduct Categories

Dietary Supplements and Natural Health Products

Whether you are a family business selling a single product, or a multi-national corporation with thousands of SKUs, the regulatory requirements are the same: it is industry’s responsibility to ensure products comply with regulations for safety, quality, efficacy, and label claims.

The dietary supplement/natural health product market is a broad category including everything from herbal products, vitamins, and minerals to omega-3s and probiotics. These products are regulated as dietary supplements in the US, natural health products (NHPs) in Canada, and food supplements in the EU.

– Product Development Strategy
– Clinical Trials
– Compliance Consulting
– Health Claims Substantiation
– Product Classification
– Technical Label Review
– Natural Health Product (NHP) Licensing
– Dietary Supplement Fact Panel Review
– Scientific Literature Reviews
– Temporary Market Authorization (TMA) Applications
– Master File Submissions
– Natural Health Product (NHP) Site Licensing
– Generally Recognized as Safe (GRAS)
– New Dietary Ingredient Notifications (NDIN)

Food and Beverages

Launching a food or beverage is a complex task laden with scientific and regulatory uncertainty. A successful product launch requires a thorough understanding of the regulations in your desired market. The requirements for food and beverage safety, manufacturing, labelling, ingredient content, and health claims differ from region to region.

– Product Development Strategy
– Clinical Trials
– Compliance Consulting
– Health Claims Substantiation
– Product Classification
– Technical Label Review
– Nutrition Facts Panel Review
– Scientific Literature Reviews
– Generally Recognized as Safe (GRAS)
– New Dietary Ingredient Notifications (NDIN)
– Medical Food Applications
– Temporary Market Authorization (TMA) Applications
– Novel Food Notifications
– Food Colouring and Additive Petitions

Medical Foods

The medical foods category is one regulatory pathway available to companies wishing to market foods intended for dietary management of patients unable to obtain nutrients through dietary modification. Typically, medical foods are used under medical supervision.

– Product Development Strategy
– Clinical Trials
– Compliance Consulting
– Health Claims Substantiation
– Product Classification
– Technical Label Review
– Nutrition Facts Panel Review
– Scientific Literature Reviews
– Generally Recognized as Safe (GRAS)
– New Dietary Ingredient Notifications (NDIN)
– Medical Food Applications
– Temporary Market Authorization (TMA) Applications
– Novel Food Notifications
– Food Colouring and Additive Petitions

Biologics

Biological dugs, or biologics, are a regulatory category encompassing living organisms and substances derived from them. Common biologics include blood products, cells, gene therapies, tissues, and vaccines. In some cases, probiotics may be classified as biologics. Regulated as pharmaceutical drugs in Canada and the US, biologics require pre-market approval before they can be sold.

Biologics pose unique regulatory and scientific challenges compared to conventional pharmaceuticals due to their complex and varied composition. Scientific evidence, including clinical trials, are used to support product safety, efficacy, and quality. Biologics are also susceptible to microbial contamination and stability concerns, making analytical and bioanalytical testing essential to ensure product quality.

– Product Development Strategy
– Clinical Trials
– Drug Establishment Licensing
– New Drug Submissions (NDS) and New Drug Applications (NDA)
– Abbreviated New Drug Submissions (ANDS) and Abbreviated New Drug Applications (ANDA)
– Clinical Project Management
– Clinical Trial Design
– Regulatory Affairs
– Early Clinical Development
– Phase II/III Clinical Trials
– Phase IV Clinical Trials
– Rescue Studies
– Feasibility Studies
– Site Selection and Management
– Monitoring
– Bioanalytics
– Medical Affairs and Pharmacovigilance
– Data Management
– Biostatistics
– Functional Services
– Pharmacy
– Archiving
– On-Site Clinical Trial Services

Pet Food and Supplements

As the market for pet foods and dietary supplements expand, more companies are looking to therapeutic claims to differentiate themselves. Regulated by Health Canada and the FDA in the US, health products intended for pets must meet compliance requirements for ingredient content, product claims, and risk to animal health.

To help you get your pet food or supplement to market quickly and efficiently, we provide expert regulatory guidance and scientific research in the areas of animal nutrition, animal health, and veterinary medicine.

– Product Development Strategy
– Clinical Trials
– Compliance Consulting
– Health Claims Substantiation
– Scientific Literature Reviews

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